Study to Develop a Prediction Model to Understand the Effect of Low-dose Aspirin on Cancer That Develops in the Colon and/or the Rectum, Diseases That Affects the Heart or Blood Vessels and Safety Outcomes in European Countries. The Study is Also Called PEACOS Model EU

NCT03904732 | Completed

• 1 other identifier: 20751
• Study Type: observational
• Target: 2,000,000
• Locations: 1 country
• Sites: 1

Brief Summary

In this study researchers want to learn more about the effect of low-dose Aspirin on cancer that develops in the colon (the longest part of the large intestine) and/or the rectum (the last several inches of the large intestine before the anus), diseases that affects the heart or blood vessels and safety outcomes. Study will focus on two groups of adults aged 50-59 and 60-69 years having an increased risk of heart and/or blood vessel disease who are taking either low-dose aspirin or no low-dose aspirin for heart and/or blood vessel disease prevention. The model will be based on information publicly available either on government organization websites or in scientific journals. Based on these data researchers will focus in a first step to build a model of 2 million adults (1 million for each age group) for the UK population and in a second step, the model will be modified for use with other European countries, to reflect the epidemiology and guidelines for aspirin use in these countries.

Conditions

Colorectal Cancer; Cardiovascular Disease; Bleeding

Outcome Measures

Primary Outcomes (8)

• Number of myocardial infarction and ischaemic stroke

  Calculated results using a mimicked population

  Up to 20 years

• Number of death due to myocardial infarction or due to ischaemic stroke

  Calculated results using a mimicked population

  Up to 20 years

• Number of colorectal cancer (CRC)

  Calculated results using a mimicked population

  Up to 20 years

• Number of death due to CRC

  Calculated results using a mimicked population

  Up to 20 years

• Number of severe gastrointestinal (GI) bleeding requiring hospitalization

  Calculated results using a mimicked population

  Up to 20 years

• Number of intracranial hemorrhage (ICH)

  Calculated results using a mimicked population

  Up to 20 years

• Number of symptomatic peptic ulcers requiring hospitalization

  Calculated results using a mimicked population

  Up to 20 years

• Number of deaths due to any other cause

  Calculated results using a mimicked population

  Up to 20 years

Study Arms (8)

Cohort 1

hypothetical UK populations of adults aged 50-59 take low-dose aspirin for primary prevention

Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)

Cohort 2

hypothetical UK populations of adults aged 50-59 take low-dose aspirin for secondary prevention

Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)

Cohort 3

hypothetical UK populations of adults aged 50-59 do not take low-dose aspirin for primary prevention

Cohort 4

hypothetical UK populations of adults aged 50-59 do not take low-dose aspirin for secondary prevention

Cohort 5

hypothetical UK populations of adults aged 60-69 take low-dose aspirin for primary prevention

Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)

Cohort 6

hypothetical UK populations of adults aged 60-69 take low-dose aspirin for secondary prevention

Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)

Cohort 7

hypothetical UK populations of adults aged 60-69 do not take low-dose aspirin for primary prevention

Cohort 8

hypothetical UK populations of adults aged 60-69 do not take low-dose aspirin for secondary prevention

Interventions

Acetylsalicylic Acid (Aspirin, BAYE4465) DRUG

Low-dose acetylsalicylic acid, Aspirin (75-150 mg)

Cohort 1; Cohort 2; Cohort 5; Cohort 6

Eligibility Criteria

• Age: 50 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Disease prediction model using hypothetical populations of adults aged 50-59 and 60-69 years at increased CVD (cardiovascular disease) risk, taking aspirin for CVD (primary or secondary) prevention.

You may qualify if:

• \- European populations (UK and other European countries) of adults aged 50-59 and 60-69 years eligible for using aspirin for primary or secondary CVD prevention. Subjects are eligible when they have no contra-indications, and are at increased risk of CVD (primary prevention) or have suffered from a previous CVD event

You may not qualify if:

• \- None

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Mimicked Population

Mimicked Population, United Kingdom

Location

Related Links

• Click here to find results for studies related to Bayer Healthcare products.

MeSH Terms

Conditions

Colorectal Neoplasms; Cardiovascular Diseases; Hemorrhage

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: April 5, 2019
• Study Start: April 15, 2019
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: February 1, 2021

Record last verified: 2021-01

Locations

GB (1)